NCT04654312

Study to Evaluate the Influence of Hydrochlorothiazide on Dermal Photosensitivity and DNA Stability - a Pilot Study (HCTox Study)

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Influence of Hydrochlorothiazide on Dermal Photosensitivity and DNA Stability - a Pilot Study (HCTox Study)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Universität des Saarlandes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The clinical trial is designed as a national, prospective, single-center, double-blind, parallel group, randomized, controlled, interventional trial to investigate whether a therapy with HCT compared with placebo can affect dermal photosensitivity and DNA stability.

Detailed description

Previously published retrospective analyses leading to the official warning about the use of hydrochlorothiazide (HCT). The underlying pilot study examins, if the intake of HCT leads to increased dermal photosensitivity and in combination with UV-exposition to a DNA-damage of the skin. Up until today, there is no prospective, randomized, placebo-controlled trial investigating the impact of HCT on dermal photosensitivity in greater detail. The pilot trial is designed as feasibility study to clarify the impact of HCT on dermal photosensitivity. This may facilitate evidence-based recommendations as to whether or not HCT increases the risk for skin cancer. Of note, HCT is one of most frequently prescribed drugs in Germany.

Conditions

• Photosensitivity

Interventions

Type	Name	Description
DRUG	Hydrochlorothiazide	Please see arm descriptions
DRUG	Placebo	Please see arm descriptions

Timeline

• Start date: 2021-01-18
• Primary completion: 2021-07-22
• Completion: 2021-07-22
• First posted: 2020-12-04
• Last updated: 2025-08-11

Locations

1 site across 1 country: Germany